PHARMACOVIGILANCE IN PRACTICE: ASSESSING ADVERSE DRUG REACTIONS IN TERTIARY CARE HOSPITAL CENTRAL INDIA
DOI:
https://doi.org/10.22159/ijpps.2025v17i2.52982Keywords:
Adverse drug reaction monitoring, Healthcare awareness, Drug safety, Causality, PharmacovigilanceAbstract
Objective: Our study aimed to evaluate the frequency, severity, and causality of ADRs reported at the ADR Monitoring Centre, Department of Pharmacology, MGM Medical College, Indore, to improve drug safety practices.
Methods: A retrospective study at the ADR Monitoring Centre in Indore analyzed suspected ADR Reporting Forms from the past six months. The analysis focused on ADR frequency, severity, and causality, categorized using the World Health Organization (WHO) causality assessment scale.
Results: Over six months, 502 ADR forms were reported at Maharaja Yashwant Rao Hospital, Indore, with males (25-55 years) accounting for 50% of the cases. The psychiatry department reported the most ADRs (57.5%), followed by pediatrics (12.1%) and gynecology (9.7%). Commonly implicated drug classes were antipsychotics, antibiotics, and anticonvulsants. Valproate (14%), ceftriaxone (8%), and olanzapine (6%) were frequently involved drugs. About 52.6% of ADRs were certain, and 25% were probable in causality analysis.
Conclusion: Monitoring and reporting ADRs are crucial in healthcare. Raising awareness about ADR reporting among doctors and patients can promote safer drug use, reduce associated ADR-related morbidity, ease the treatment burden on patients, and enhance their quality of life.
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Brahmbhatt SV, Rajput M. Pharmacovigilance. Int J Health Sci. 2022;6(6):6618-21. doi: 10.53730/ijhs.v6nS4.11263.
Abbood MK, Khalaf HA, Abudlqader EH, Taghi HS, Al Temimi AA. Scope of pharmacovigilance: a comprehensive review. Chem Sci Int J. 2022;31(5):29-39. doi: 10.9734/CSJI/2022/v31i5822.
Zatovkanukova P, Sliva J. The position and importance of pharmacovigilance in the czech republic and the world. Vnitr Karr Stvii. 2022;68(3):E10-5. doi: 10.36290/vnl.2022.054.
Mueller M, Lewis D, Alexe A. The evolution of pharmacovigilance ecosystems: does moores law invite the use of ockhams razor? Authorea. 2022;89(2):470-82. doi: 10.1111/bcp.15573.
Bhardwaj K, Alam R, Pandeya A, Sharma PK. Artificial intelligence in pharmacovigilance and COVID-19. Curr Drug Saf. 2023;18(1):5-14. doi: 10.2174/1574886317666220405115548, PMID 35382726.
Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over pharmacovigilance. Int J Clin Pharm. 2018;40(4):744-7. doi: 10.1007/s11096-018-0657-1, PMID 29948743.
Caron J, Rochoy M, Gaboriau L, Gautier S. Histoire de la pharmacovigilance. Therapies. 2016;71(2):123-8. doi: 10.1016/j.therap.2016.02.026.
Ibara M, Richesson RL. The evolution of pharmacovigilance in the age of digital healthcare. Back to the Future. Comput Health Care. 2019:433-51.
Elshafie S, Zaghloul I, Roberti AM. Pharmacovigilance in developing countries (Part I): importance and challenges. Int J Clin Pharm. 2018;40(4):758-63. doi: 10.1007/s11096-017-0570-z, PMID 29248988.
Sen M, Singh A, Misra M. Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in A Tertiary Care Hospital. Int J Basic Clin Pharmacol. 2018;7(2):303. doi: 10.18203/2319-2003.ijbcp20180103.
Omar IH, Harris E. The use of social media in ADR monitoring and reporting. J Pharmacovigilance. 2016;4(6):6. doi: 10.4172/2329-6887.1000223.
Kaur I, Kalaiselvan V, Kumar R, Mishra P. Reporting of adverse drug reactions by pharmacists in the pharmacovigilance programme of India: a perspective. Curr Overview Pharm Sci. 2023;7(2):128-34. doi: 10.9734/bpi/cops/v7/9451F.
Brahmbhatt S, Rajput M. Pharmacovigilance: significance and challenges. Int J Health Sci. 2022;5(6):860-3. doi: 10.53730/ijhs.v6nS5.11201.
Mc Ananey BT, Bandon WE, Stephen DK, Mattson TL, Patrick KP, Testa JK. Methods and systems for managing invention disclosures; 2000.
Prakash J, Sachdeva R, Shrivastava TP, Jayachandran CV, Sahu A. Adverse event reporting tools and regulatory measures in India through outcome of pharmacovigilance programme of India. Indian J Pharmacol. 2021;53(2):143-52. doi: 10.4103/ijp.ijp_901_20, PMID 34100398.
World Health Organization. Guidelines for the regulatory assessment of medicinal products for use in self medication. World Health Organization; 2000. Available from: https://www.scirp.org/reference/referencespapers?referenceid=1912686.
Buabeng RO, Dsane Aidoo P, Asamoah YK, Bandoh DA, Boahen YA, Sabblah GT. Under reporting of adverse drug reactions: surveillance system evaluation in ho municipality of the volta region ghana. Plos One. 2023;18(9):e0291482. doi: 10.1371/journal.pone.0291482, PMID 37699058.
Alghazwani Y, Alqahtani AM, Alshuraymi MK, Assiri IM, Shuflut AA, Krishnaraju V. The perspective of pharmacist on pharmacovigilance and adverse drug reaction reporting in Asir region Saudi Arabia. Eur Rev Med Pharmacol Sci. 2023;27(4):1667-80. doi: 10.26355/eurrev_202302_31410, PMID 36876701.
Aagaard L, Strandell J, Melskens L, Petersen PS, Holme Hansen EH. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to Vigi Base™. Drug Saf. 2012;35(12):1171-82. doi: 10.1007/BF03262002, PMID 23072620.
Potlog Shchory MP, Goldstein LH, Arcavi L, Shihmanter R, Berkovitch M, Levy A. Increasing adverse drug reaction reporting how can we do better? Plos One. 2020;15(8):e0235591. doi: 10.1371/journal.pone.0235591, PMID 32790671.
Yawson AA, Abekah Nkrumah G, Okai GA, Ofori CG. Awareness knowledge and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana. Ther Adv Drug Saf. 2022;13(1):20420986221116468. doi: 10.1177/20420986221116468, PMID 35966898.
Sharma M, Baghel R, Thakur S, Adwal SK. Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7 y surveillance study. BMJ Open. 2021;11(10):e052737. doi: 10.1136/bmjopen-2021-052737, PMID 34607871.
Raveendran N, Kumar SK, Rai M, Ravindran A, Chandrashekar R. Precedence of cognizant adverse drug reactions (ADRs) reporting in a South Indian Tertiary Care Hospital: a prospective study. Indian J Pharm Pharmacol. 2016;3(2):39-43. doi: 10.5958/2393-9087.2016.00008.X.
Patel JJ, Shah MK, Patel PP, Gandhi AM, Desai MK. Knowledge attitude and practice among consumers about adverse drug reaction reporting. Int J Basic Clin Pharmacol. 2019;8(8):1776-80. doi: 10.18203/2319-2003.ijbcp20193177.
Khanna S, Singh DK, Shankar P, Tutu S, Lakhani P, Dixit RK. A survey to assess knowledge attitude and practices among doctors about pharmacovigilance. World J Pharm Sci. 2015;3(12):2292-514.
Joshi D, Gupta S, Singh TG, Parashar A, Singh SK. A qualitative evaluation of ADR reporting in India: non-regulatory confronts and their possible solutions. ECS Trans. 2022;107(1):6763-80. doi: 10.1149/10701.6763ecst.
Mascolo A, Scavone C, Sessa M, DI Mauro G, Cimmaruta D, Orlando V. Can causality assessment fulfill the new European definition of adverse drug reaction? a review of methods used in spontaneous reporting. Pharmacol Res. 2017 Sep;123:122-9. doi: 10.1016/j.phrs.2017.07.005, PMID 28694146.
Sunitha M, Parvathy S. A study of agreement between WHO uppsala monitoring centre criteria naranjo algorithm and liverpool algorithm for causality assessment of adverse drug reactions. Int J Pharm Pharm Sci. 2021;20(2):20-2. doi: 10.22159/ijpps.2021v13i1.39800.
DA Silva RF. Causality assessment in pharmacovigilance: principles and fundamentals of causal inference. Rev Salus. 2022;4(3):45-50.
Mascolo A, Scavone C, Sessa M, DI Mauro G, Cimmaruta D, Orlando V. Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting. Pharmacol Res. 2017;123:122-9. doi: 10.1016/j.phrs.2017.07.005, PMID 28694146.
SP, KM, SA. Causality severity and preventability assessment of adverse cutaneous drug reaction: a prospective observational study in A Tertiary Care Hospital. J Clin Diagn Res. 2013;7(12):2765-7. doi: 10.7860/JCDR/2013/7430.3753, PMID 24551632.
Ganjikunta RK, Kadali RP, Arora T, Chalivendra P. Evaluation of cutaneous adverse drug reactions reported in a teaching hospital of Coastal Andhra. Biomed Pharmacol J. 2023;16(2):1113-9. doi: 10.13005/bpj/2691.
Sivakumar V, D AC, VD, SK, TK. Analysis of voluntary reported adverse drug reactions in A Tertiary Care Hospital. Int J Basic Clin Pharmacol. 2023;12(3):406-9. doi: 10.18203/2319-2003.ijbcp20231119.
Pathak AK, Kumar M, Dokania S, Mohan L, Dikshit H. A retrospective analysis of reporting of adverse drug reactions in A Tertiary Care Teaching Hospital: One year survey. J Clin Diagn Res. 2016;10(8):FC01-4. doi: 10.7860/JCDR/2016/18826.8284, PMID 27656459.
Modi A, Desai M, Shah S, Shah B. Analysis of cutaneous adverse drug reactions reported at the regional ADR monitoring center. Indian J Dermatol. 2019;64(3):250. doi: 10.4103/ijd.IJD_682_16, PMID 31148872.
Jindal A, Brar BK, Kumar R, Kumar S, Sidhu K, Kaur A. Pattern of adverse drug reactions with chemotherapeutic drugs in A Tertiary Care Hospital of North India: A retrospective study. Int J Basic Clin Pharmacol. 2023;12(2):236-9. doi: 10.18203/2319-2003.ijbcp20230394.
Gurpoonam J, Kumar GS, Sandeep K, Shobhna K, Sandeep K. Cutaneous adverse drug reactions: a one-year prospective study. Iran J Dermatol. 2017;20(4):103-12.
Kaur K, Kanwal P, Goyal P, Singh P, Yakhmi S, Jain S. Spontaneous adverse drug reaction monitoring in A Tertiary Care Centre. Curr Drug Saf. 2020;15(3):215-21. doi: 10.2174/1574886315666200731172405, PMID 32735525.
Princy E, Olisha DM, Dhawal S, Jitendra V. A cross-sectional pharmacovigilance study on adverse drug reaction in A Tertiary Care Teaching Hospital. Asian J Pharm Clin Res. 2022;15(1):103-6. doi: 10.22159/ajpcr.2022.v15i1.42347.
Patil S, Gade R, BR, YV, VY. An annual retrospective analysis of adverse drug reactions reported at adverse drug reaction monitoring center Nalgonda. Natl J Physiol Pharm Pharmacol. 2021;12(1):26-9. doi: 10.5455/njppp.2022.11.07256202124072021.
Giri K, Palandurkar K, Giri R, Agrawal UK. A retrospective pharmacovigilance analysis at Tertiary Care Hospital: an observational study. Asian J Pharm Clin Res. 2022;15(8):51-6. doi: 10.22159/ajpcr.2022.v15i8.45019.
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Copyright (c) 2025 AVINA KHARAT, POOJA SOLANKI MISHRA, MEGHNA SHINDE, ANERI PATEL, NARLAPATI VIGNAN
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